A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 50 participants (planned 30)
    • Primary completion date changed from estimate of Aug 20, 2026 to Aug 6, 2026
    • Study completion date changed from estimate of Aug 20, 2026 to Aug 10, 2026
    • Eligibility criteria expanded, about 25 words
  2. Primary and study completion dates pushed to Aug 20, 2026
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 9, 2024 to Oct 18, 2024
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts: Part A, conducted : SAD stage Part B, conducted: MAD stage
Trial Details
NCT Number NCT06494527
Lead Sponsor Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Conditions
(from sponsor)		 Safety Issues
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov